WO2022218127A1 - Neurostimulateur implantable - Google Patents

Neurostimulateur implantable Download PDF

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Publication number
WO2022218127A1
WO2022218127A1 PCT/CN2022/082968 CN2022082968W WO2022218127A1 WO 2022218127 A1 WO2022218127 A1 WO 2022218127A1 CN 2022082968 W CN2022082968 W CN 2022082968W WO 2022218127 A1 WO2022218127 A1 WO 2022218127A1
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WO
WIPO (PCT)
Prior art keywords
main control
stimulation
control chip
circuit
implantable
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PCT/CN2022/082968
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English (en)
Chinese (zh)
Inventor
徐天睿
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北京领创医谷科技发展有限责任公司
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Priority to EP22787356.9A priority Critical patent/EP4324512A1/fr
Publication of WO2022218127A1 publication Critical patent/WO2022218127A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • A61N1/36135Control systems using physiological parameters
    • A61N1/36139Control systems using physiological parameters with automatic adjustment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source

Definitions

  • the invention relates to an implantable nerve stimulator, which forms a nerve stimulation system together with an external energy controller through radio frequency communication.
  • the present invention relates to an implantable neurostimulator with a main control chip.
  • Neurostimulation systems incorporating implantable neurostimulators have been widely used in the medical field.
  • an implantable neurostimulator is implanted into a patient to effect treatment of the patient site.
  • the treatment regimen includes, for example, the pulse width, frequency, etc. of the stimulation pulses. This is undoubtedly painful for patients with long treatment cycles.
  • Chinese invention patents CN104080509B and CN107789730B disclose such neural stimulator systems.
  • the implantable neurostimulator performs radio frequency communication and energy transmission with the external energy controller, and the external energy controller provides electrical stimulation pulses in real time to drive the stimulation electrodes of the implantable neurostimulator, thereby applying stimulation to the patient's treatment site. and the external energy controller provides radio frequency electric energy to the implantable neural stimulator to maintain the operation of the implantable neural stimulator.
  • radio frequency-based neurostimulators can obtain an almost endless supply of power, so there is no need to worry about battery drain. Moreover, this radio frequency-based implantable neurostimulator can adjust the electrical stimulation pulse at any time by the external energy controller according to the treatment plan. So there is no need to worry about repeated implants due to battery drain and changing treatment regimens.
  • CN107789730B adopts a dual-frequency working mode, at the cost of increasing the complexity of the product and manufacturing cost, and may lead to an increase in the size of the implantable neurostimulator. And this volume increase is obviously not conducive to the implantation of neurostimulators.
  • the electrical stimulation pulses of the implantable neurostimulator are provided by the external controller in real time, it is necessary to ensure reliable communication between the neurostimulator implanted in the patient and the external controller.
  • the reliability of this communication will be affected by many factors. For example, when the external energy controller is far away from the patient for some reason, or when the external energy controller is accidentally impacted or damaged, even for a very short time, the treatment process of the implantable neurostimulator will be detrimental. influences.
  • the purpose of the present invention is to provide an implantable neural stimulator, which forms a neural stimulation system together with an external energy controller through radio frequency communication.
  • the nerve stimulation system can also include upper computer software to facilitate operation and setting. Its characteristic is that the operation control of the implantable neurostimulator is not completed by the external energy controller, but is realized by the main control chip built in the implantable neurostimulator. Thereby, the problems of treatment safety and product complexity caused by the need for real-time communication in the prior art implantable neurostimulator system are overcome.
  • an implantable neurostimulator which communicates with an external energy controller and receives electrical energy by radio frequency, and includes: a main control chip, which includes a main control CPU and a main control memory and a digital-to-analog conversion current source circuit (DAC); a stimulator antenna and an impedance matching circuit thereof, which are radio-frequencyly coupled to an external energy controller to receive an input signal containing electrical energy and control information from the external energy controller, and can send an input signal to the external energy controller.
  • a main control chip which includes a main control CPU and a main control memory and a digital-to-analog conversion current source circuit (DAC); a stimulator antenna and an impedance matching circuit thereof, which are radio-frequencyly coupled to an external energy controller to receive an input signal containing electrical energy and control information from the external energy controller, and can send an input signal to the external energy controller.
  • DAC digital-to-analog conversion current source circuit
  • the energy controller sends data;
  • the rectification energy storage circuit is connected to the impedance matching circuit and the main control chip respectively, so as to extract and store electric energy from the received input signal, and supply power to the main control chip;
  • a modulation/demodulation circuit which is connected to the impedance matching circuit and the main control chip, so as to extract control information from the received input signal, transmit the control information to the main control chip, and transmit the control information to the main control chip.
  • the data is modulated and transmitted to the impedance matching circuit, and sent to the external energy controller through the stimulator antenna;
  • the electrode interface is connected to the main control chip, and receives the polarity assignment information from the main control chip, and converts it from digital to analog a current source circuit receives a sequence of stimulation pulses; one or more stimulation electrodes connected to the electrode interface, the electrode interface assigns the sequence of stimulation pulses to each corresponding stimulation electrode according to polarity assignment information; wherein the main The control memory stores a control program and stores the received control information.
  • the main control CPU runs the control program to control the digital-to-analog conversion current source circuit to generate the stimulation pulse sequence according to the control information.
  • the control information includes a clinical stimulation parameter combination that is a parameter combination of a polarity assignment information parameter, a pulse width parameter, a pulse amplitude parameter, and a pulse frequency parameter.
  • the main control memory is a non-volatile memory.
  • the clinical stimulation parameter combination includes multiple groups, each group of clinical stimulation parameter combination has its own code, and the control information further includes a clinical stimulation parameter code.
  • the parameter codes are in one-to-one correspondence with codes of multiple sets of clinical stimulation parameter combinations stored in the main control memory.
  • control information further includes an up/down gear control instruction
  • the main control chip adjusts the pulses of the stimulation pulse sequence in a stepwise manner in response to the up/down gear control instruction strength.
  • control information further includes a data read instruction
  • the main control CPU sends the corresponding data stored in the main control memory to the external energy control device in response to the data read instruction. device.
  • the parameters of the clinical stimulation parameter combination further include a charge balance time, and the length of the charge balance time is sufficient to ensure that the charges between adjacent electrical stimulation pulses are fully released , so as to achieve passive charge balance.
  • a charge balance circuit is also connected between the electrode interface and the digital-to-analog conversion current source circuit of the main control chip, and the charge balance circuit can be used in adjacent electrical stimulation pulses. A reverse pulse is applied to the electrode interface between them to achieve active charge balance.
  • implantable neural stimulator preferably, it further includes an operating data memory, which is electrically connected to the main control chip and used to store various operating data generated during the operation of the implantable neural stimulator.
  • the control information further includes a data read instruction, and the main control CPU sends the data stored in the operating data memory to the external energy controller in response to the data read instruction.
  • the operating data memory is a non-volatile memory.
  • implantable neurostimulator preferably, it further includes a post-measurement feedback circuit, and the post-measurement feedback circuit is respectively connected to the electrode interface and the main control chip, so as to measure the real-time stimulation on the stimulation electrodes parameters are transmitted to the main control chip, and the main control chip stores the real-time stimulation parameters in the operating data memory.
  • the main control chip compares the real-time stimulation parameters with the clinical stimulation parameters, and corrects the stimulation signal applied to each stimulation electrode according to the comparison result .
  • implantable nerve stimulator preferably, it further includes a pre-measurement feedback circuit, and the pre-measurement feedback circuit is arranged between the rectifier energy storage circuit and the main control chip, so as to measure all the parameters at any time.
  • the real-time electric energy storage amount in the rectifier energy storage circuit is transmitted to the main control chip, and the main control chip stores the real-time electric energy storage amount in the operation data memory.
  • the main control chip evaluates whether it is necessary to adjust the electric energy input by the radio frequency according to the real-time electric energy storage amount, and when the real-time electric energy storage amount is lower than the set value, The main control chip sends a power adjustment command to the external energy controller antenna through the stimulator antenna and its impedance matching circuit, so as to adjust the transmission power of the external energy controller.
  • the main control chip controls the implantable neural stimulator, and periodically sends various operating data stored in the operating data memory to the external energy controller.
  • the implantable nerve stimulator of the present invention can achieve the following beneficial technical effects. Since the electric pulse stimulation is implemented based on the combination of treatment parameters stored in its own main control memory, it is only necessary to provide radio frequency electric energy from the external energy controller, and it is not necessary to obtain real-time stimulation signals containing stimulating electrical pulses from the external energy controller. Improve the reliability of implantable neurostimulator operation, without worrying about treatment failure due to sudden communication interruption or poor communication.
  • the memory of the implantable neurostimulator can store various operating parameters, and can send these data to the external energy controller during intermittent periods of treatment or when the communication is not busy, it can further ensure the smooth communication when communication is required, thereby improving the equipment. performance.
  • Figure 1 shows a functional block diagram of one embodiment of a neurostimulation system incorporating the implantable neurostimulator of the present invention.
  • Figure 2 shows a functional block diagram of another embodiment of a neurostimulation system incorporating the implantable neurostimulator of the present invention.
  • FIG. 3 shows a functional block diagram of the implantable neurostimulator of the present invention.
  • FIG. 4 shows a functional block diagram of another implantable neurostimulator of the present invention.
  • Figure 1 shows a functional block diagram of one embodiment of a neurostimulation system incorporating the implantable neurostimulator of the present invention.
  • the neural stimulation system includes two parts: an implantable neural stimulator 1 and an external energy controller 2.
  • Figure 2 shows a functional block diagram of another embodiment of a neurostimulation system incorporating the implantable neurostimulator of the present invention.
  • the embodiment in FIG. 2 adds a host computer 3 .
  • the host computer is not necessary. Adding a host computer helps to improve the human-computer interaction function, making it easier for doctors or patients to operate the neurostimulation system, and to set more complex functions for the neurostimulation system.
  • FIG. 3 shows a functional block diagram of the implantable neurostimulator of the present invention.
  • the implantable neurostimulator 1 of the present invention which communicates with the external energy controller and receives electrical energy by radio frequency, includes: a main control chip 11, and the main control chip includes a main control CPU 111, The main control memory 112 and the digital-to-analog conversion current source circuit (i-DAC) 113; the stimulator antenna and its impedance matching circuit 12, which are RF-coupled with the external energy controller to receive information including power and control from the external energy controller input signal, and can send data to the external energy controller; rectifier energy storage circuit 13, which is respectively connected to the impedance matching circuit 12 and the main control chip 11, so as to extract and store electrical energy from the received input signal power supply to the main control chip 11; modulation/demodulation circuit 14, which is connected to the impedance matching circuit 12 and the main control chip 11, so as to extract control information from the received input signal, and to The control information is transmitted to the main control chip 11, and the data sent by the main control chip 11 is modulated and then transmitted to the impedance matching circuit, and sent
  • the main control memory 112 is preferably non-volatile memory so that data can be stored even after a power failure. In this way, the implantable neurostimulator 1 only needs to be configured for each patient according to the treatment plan before each treatment stage, and it can be applied to the whole treatment stage. Therefore, frequent settings of the implantable neurostimulator 1 by the physician are avoided.
  • the clinical stimulation parameter combination may include multiple groups, each group of clinical stimulation parameter combination has its own code, the control information further includes clinical stimulation parameter code, the clinical stimulation parameter code and the multiple groups of clinical stimulation parameters stored in the main control memory.
  • the codes for stimulus parameter combinations correspond one-to-one. In this way, the user (doctor or patient) can directly call the corresponding treatment plan (corresponding to the corresponding clinical stimulation parameter combination) by operating the external energy controller according to the treatment process. It avoids the trouble of frequently configuring implantable neurostimulators as the patient's condition improves.
  • the above-mentioned control information further includes an up/down shift control instruction, and the main control chip 11 adjusts the pulse intensity of the stimulation pulse sequence in a stepwise manner in response to the up/down shift control instruction. In this way, patients can adjust the intensity of stimulation at any time according to their own experience.
  • the control information further includes a data read instruction, and the main control CPU sends the corresponding data stored in the main control memory to the external energy controller 2 in response to the data read instruction.
  • the patient or doctor can obtain various combination of treatment parameters stored in the implantable neurostimulator 1, and can also obtain the data generated by the operation of the implantable neurostimulator 1.
  • Implantable neurostimulators use sequences of stimulation pulses to treat patients.
  • the pulse frequency is high, the charge between adjacent stimulation pulses cannot be fully released, thus making the actual pulse waveform sequence different from the pulse waveform sequence required for treatment. This will affect the effectiveness of the treatment and also reduce the lifespan of the implantable neurostimulator itself.
  • the parameters of the clinical stimulation parameter combination further include a charge balance time, and the length of the charge balance time is sufficient to ensure that the charges between adjacent electrical stimulation pulses are fully released, so as to achieve passive charge balance. This overcomes the problem that the electric charge between adjacent electrical stimulation pulses existing in the existing neural stimulator cannot be released.
  • a charge balance circuit 17 is also connected between the electrode interface 15 and the digital-to-analog conversion current source circuit 113 of the main control chip 11 , and the charge balance circuit 17 can Active charge balancing is achieved by applying reverse pulses to the electrode interface 15 between adjacent electrical stimulation pulses. Compared with passive charge balancing of natural discharge, active charge balancing can complete the discharge process faster. Clearly, this active charge balancing allows for higher stimulation pulse frequencies. Conversely, the charge balancing circuit 17 is not necessary, depending on the frequency of the stimulation pulses used by the implantable neurostimulator 1 .
  • the implantable neural stimulator 1 further includes an operating data storage 18 for storing various operating data generated during the operation of the implantable neural stimulator.
  • the control information received from the external energy controller also includes a data reading instruction, and the main control CPU 111 sends the data stored in the operating data memory 18 to the external energy controller 2 in response to the data reading instruction.
  • the operating data memory 18 is not necessary, and various operating data generated during the operation of the implantable neurostimulator can also be stored in a certain partition of the main control memory 112, as long as the storage capacity of the main control memory is sufficient Big enough.
  • the operating data memory 18 is preferably a non-volatile memory in order to store data even after a power failure. In this way, within the range allowed by the storage space, the external energy controller can retrieve the operation data of the implantable neural stimulator as needed within a period of time. Data loss due to sudden communication interruption is also prevented.
  • the implantable nerve stimulator 1 further includes a post-measurement feedback circuit 19, and the post-measurement feedback circuit 19 is respectively connected to the electrode interface 15 and the main control chip 11, so as to measure
  • the real-time stimulation parameters on the stimulation electrodes 16 are transmitted to the main control chip 11 , and the main control chip stores the real-time stimulation parameters in the operation data memory 18 .
  • the main control chip 11 can compare the real-time stimulation parameters with the stored clinical stimulation parameters, and correct the stimulation signals applied to each stimulation electrode according to the comparison results.
  • the post-measurement feedback circuit is not necessary.
  • the implantable neurostimulator can be designed into a simple and reliable working mode without the need to measure the working parameters of the stimulation electrodes. Doing so helps keep costs down.
  • the implantable nerve stimulator 1 shown in FIG. 3 further includes a pre-measurement feedback circuit 10 , and the pre-measurement feedback circuit 10 is arranged between the rectifier energy storage circuit 13 and the main control chip 11 , so as to measure the real-time electric energy storage amount in the rectifier energy storage circuit 13 at any time and transmit it to the main control chip 11 , and the main control chip stores the real-time electric energy storage amount in the operation data memory 18 .
  • the main control chip 11 evaluates whether it is necessary to adjust the electric energy input by the radio frequency according to the real-time electric energy storage amount. When the real-time electric energy storage amount is lower than the set value, the main control chip 11 passes the stimulator antenna and its impedance matching circuit. 12 Send a power adjustment command to the antenna of the external energy controller 2, so as to adjust the transmit power of the external energy controller 2.
  • the implantable neurostimulator 1 of the present invention has a main control memory and an operating data memory.
  • the main control chip 11 can actively send data to the external energy controller, that is, periodically send various data stored in the main control memory and/or operating data memory to the external energy controller.
  • the main control chip 11 only includes the main control CPU 111, the main control memory 112 and the digital-to-analog conversion current source circuit (i-DAC) 113, wherein the circuit part is used as Peripheral circuits.
  • i-DAC digital-to-analog conversion current source circuit
  • part of the pre-measurement feedback circuit, modulation/demodulation circuit, electrode interface, charge balance circuit, operating data memory and post-measurement feedback circuit can also be used. Or all are designed in the main control chip 11 .
  • part of the pre-measurement feedback circuit, modulation/demodulation circuit, electrode interface, charge balance circuit, operating data memory and post-measurement feedback circuit can also be used. Or all are designed in the main control chip 11 .
  • FIG. 1 in the principle block diagram of another implantable neurostimulator shown in FIG.
  • the main control chip 11 includes a main control CPU 111, a main control memory 112 and a digital-to-analog conversion current source circuit (i-DAC) 113, Pre-measurement feedback circuit 110 , modulation/demodulation circuit 114 , electrode interface 115 , charge balance circuit 117 , operating data memory 118 , and post-measurement feedback circuit 119 .
  • i-DAC digital-to-analog conversion current source circuit
  • the implantable neural stimulator 1 of the present invention is configured with parameters by the external energy controller, and is activated and started to work by the external energy controller. Once activated, the implantable neurostimulator 1 starts to operate actively depending on the configured parameters, and completes the electrode pulse stimulation therapy for the patient.
  • the implantable nerve stimulator 1 of the present invention is provided with a rectifier energy storage circuit 13, and the electrical energy stored in the rectifier energy storage circuit 13 is supplied to the entire implantable nerve stimulator 1 to operate. At the same time, the rectifier energy storage circuit 13 receives the radio frequency electric energy of the external energy controller 2 for charging, so as to maintain the continuous operation of the implantable nerve stimulator 1 . The amount of electrical energy stored in the rectified tank circuit 13 can be monitored by the pre-measurement circuit. When the electrical energy storage capacity decreases, the implantable neural stimulator 1 will send an instruction to the external energy controller 2, and the external energy controller 2 will increase the transmission power.
  • the implantable neural stimulator 1 of the present invention implements electrical pulse stimulation based on the combination of treatment parameters stored in its own main control memory, so it only needs to provide radio frequency electrical energy from the external energy controller, and does not need to obtain radio frequency energy from the external energy controller.
  • Real-time stimulation signals containing stimulating electrical pulses Therefore, even if the communication is interrupted or the communication is poor due to an emergency, the treatment will not fail.
  • the implantable neurostimulator of the present invention can continue to operate for a period of time until the communication returns to normal. Not to interrupt treatment.
  • the implantable neural stimulator of the present invention can further ensure that the Smooth communication during communication, thereby improving the performance of the device. For example, while the doctor or patient operates the external energy controller to send instructions to the implantable neurostimulator, the implantable neurostimulator will not send data to the outside to ensure smooth communication.

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  • Life Sciences & Earth Sciences (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

Neurostimulateur implantable, communiquant avec un dispositif de commande d'énergie in vitro et recevant de l'énergie électrique au moyen d'une radiofréquence. Le neurostimulateur implantable comprend : une puce de commande principale, la puce de commande principale comprenant une CPU de commande principale, une mémoire de commande principale et un circuit de source de courant à conversion numérique-analogique ; une antenne de stimulateur et un circuit d'adaptation d'impédance de cette dernière, l'antenne de stimulateur étant couplée au dispositif de commande d'énergie par radiofréquence ; un circuit de stockage d'énergie de redresseur, extrayant de l'énergie électrique à partir d'un signal d'entrée reçu et la stockant ; un circuit de modulation/démodulation, extrayant, à partir du signal d'entrée reçu, des informations de commande comprenant des paramètres de stimulation clinique ; une interface d'électrode ; et une ou plusieurs électrodes de stimulation, l'interface d'électrode distribuant des séquences d'impulsions de stimulation aux électrodes de stimulation correspondantes respectives. La mémoire de commande principale stocke les informations de commande reçues, le circuit de source de courant à conversion numérique-analogique génère les séquences d'impulsions de stimulation selon les paramètres de stimulation clinique, et la CPU de commande principale commande le fonctionnement du neurostimulateur implantable. Le neurostimulateur implantable de la présente invention peut éviter une défaillance de traitement provoquée par une communication par radiofréquence interrompue ou non fluide.
PCT/CN2022/082968 2021-04-16 2022-03-25 Neurostimulateur implantable WO2022218127A1 (fr)

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Application Number Priority Date Filing Date Title
EP22787356.9A EP4324512A1 (fr) 2021-04-16 2022-03-25 Neurostimulateur implantable

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CN202110412272.2 2021-04-16
CN202110412272.2A CN112972895A (zh) 2021-04-16 2021-04-16 植入式神经刺激器

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CN117582605A (zh) * 2024-01-16 2024-02-23 北京领创医谷科技发展有限责任公司 一种电场耦合式神经刺激系统

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CN113457014A (zh) * 2021-08-03 2021-10-01 苏州景昱医疗器械有限公司 体外程控器及其控制电路、程控系统
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CN117101003B (zh) * 2023-09-11 2024-02-27 北京领创医谷科技发展有限责任公司 一种基于能控器电量的神经刺激器控制方法及装置

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CN104080509B (zh) 2011-07-29 2017-09-08 米克伦设备有限责任公司 用于神经刺激器的功率或极性选择的远程控制
CN107789730B (zh) 2011-07-29 2020-11-10 米克伦设备有限责任公司 用于神经刺激器的功率或极性选择的远程控制
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CN105311750A (zh) * 2015-11-09 2016-02-10 杭州承诺医疗科技有限公司 一种骶神经刺激系统
CN112972895A (zh) * 2021-04-16 2021-06-18 北京领创医谷科技发展有限责任公司 植入式神经刺激器
CN216295009U (zh) * 2021-04-16 2022-04-15 北京领创医谷科技发展有限责任公司 植入式神经刺激器

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CN116421887A (zh) * 2023-05-17 2023-07-14 北京领创医谷科技发展有限责任公司 刺激器的软启动控制方法及系统
CN117582605A (zh) * 2024-01-16 2024-02-23 北京领创医谷科技发展有限责任公司 一种电场耦合式神经刺激系统
CN117582605B (zh) * 2024-01-16 2024-04-30 北京领创医谷科技发展有限责任公司 一种电场耦合式神经刺激系统

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